The Committee for Risk Assessment in European Pharmacovigilance has carried out a new assessment of the benefit / risk balance of valproic acid when administered to girls, women with gestational capacity and pregnant women. The compound is an anticonvulsant with a broad spectrum of antiepileptic activity., whose main mechanism of action is related to the increase in the inhibitory action of the GABA neurotransmitter.
This neurotransmitter is a four-carbon amino acid present in some animals and plants, also in bacteria; in animals it is found in the brain in high concentrations
The administration of valproic acid implies risk of developing congenital malformations, and in addition recent studies indicate that its use during pregnancy may be associated with alterations in the physical and neurodevelopmental development of children exposed in utero.
The most common malformations are: neural tube defects, facial dysmorphia, cleft palate and cleft lip, craniosynostosis, heart, kidney and urogenital defects, limb defects (including bilateral radius aplasia) and multiple abnormalities with involvement of various organs and systems .
Could not determine exactly what the gestational period of risk is, and the permanence of this during the whole pregnancy is not ruled out.
Studies in early childhood children who were exposed showed that between 30 and 40 percent of these had some early developmental disorder related to verbal communication, intellectual quotient, memory and gross motor skills.
There could also be an increase in the risk of childhood autism and other autism spectrum disorders. (comparing with the general population). On the other hand, limited data suggest that these children may be at greater risk of developing ADHD.
These are therefore the recommendations that AEMPS addresses to health professionals
Valproic acid should not be given to girls, to women with gestational capacity or to pregnant women, unless other therapies for the treatment of epilepsy or manic episodes associated with bipolar disorder have not been tolerated or have proven ineffective.
Women with gestational capacity in treatment with valproic acid should use an effective contraceptive method during the entire duration of the treatment and will explain in detail the risks that the fetus will run in case of pregnancy.
Women in treatment should be informed that in case of pregnancy they should not suspend the medication without consulting before your doctor
If a woman becomes pregnant while taking valproic acid, a thorough assessment of the benefits and risks will be made, considering other therapeutic alternatives. If it is finally decided to continue with the treatment, the guidelines indicated in the document linked above will be followed.
The AEMPS is updating the fact sheets and leaflets of medicines with valproic acid, which will soon be available on their website, along with supplementary informational material for both healthcare professionals and patients.
The importance of report all suspected reactions Adverse to the corresponding Autonomous Pharmacovigilance Center of the SEFV-H, and can also be notified through the electronic form available on this website.
